# FDA WARNING_LETTER - True Vape USA - September 10, 2019

Source: https://www.globalkeysolutions.net/records/warning_letter/true-vape-usa/69331dd0-04a4-4ab1-b393-da8ccb2c3be4

> FDA WARNING_LETTER for True Vape USA on September 10, 2019. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: True Vape USA
- Inspection Date: 2019-09-10
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: The FDA's Center for Tobacco Products issued a Warning Letter to True Vape USA after reviewing their website, truevapeusa.com, and determining that their e-liquid products are tobacco products subject to FDA jurisdiction. The letter identifies two primary violations. First, True Vape USA sold Bazooka Sour Straws Tropical Thunder - Mango Tango Sour Straws e-liquid to a person younger than 18 years of age, which is a violation of 21 C.F.R. § 1140.14(b) and renders the product misbranded under section 903(a)(7)(B) of the FD&C Act. Second, the company's website advertising for several e-liquid products, including Joker – Cloud Nine and Sher Burst, failed to include the required nicotine warning statement ("WARNING: This product contains nicotine. Nicotine is an addictive chemical.") as mandated by 21 C.F.R. § 1143.3(b), also resulting in misbranded products under section 903(a)(7)(B) of the FD&C Act. True Vape USA is required to immediately correct these violations and submit a written response within 15 working days detailing corrective actions, including dates of discontinuance of violative activities, and a plan for future compliance. Failure to comply may lead to further FDA actions, such as civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction.

## Related Officers

- [Director](https://www.globalkeysolutions.net/people/ann-simoneau/155ef03c-6b60-4063-b35d-75522fa67d2b)
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Company: https://www.globalkeysolutions.net/companies/true-vape-usa/a300c0c0-96c3-4aba-801d-3afea50ccdd8

Office: https://www.globalkeysolutions.net/offices/center-for-tobacco-products/65f73cae-ef6f-4e9f-a311-a111daa67374